Research and Testing

The research and testing programs to date have been aimed at evaluating the effectiveness and safety of the LDAC technology in different animals and tumor models, optimizing treatment effects by testing different parameters — such as treatment duration, probe configuration, power and temperature ceilings — and understanding the mechanism of action that underlies the treatment effect.

By working with the University of Washington Genitourinary Research Laboratory and ­­­ BioDevelopment Associates in Seattle, WA, the Company has completed 17 non-clinical studies including a GLP safety study.

Observations and Results

Over the course of the studies, there were numerous significant observations that support the preferential nature of the LDAC cancer treatment technology.

When critical treatment parameters such as voltage, current and temperature are maintained within a precise range, tumor cells are destroyed within the treatment volume.

Histological analysis of treated tumors suggests that tumor cell necrosis within the treatment volume are not the result of thermal ablation. While there are some isolated areas of thermal necrosis, the majority of necrosis does not appear to be the result of thermal ablation normally associated with excessive temperature.

The LDAC device was effective in treating human prostate cancer implants using single treatment durations of 15 minutes.

Cardiac and nervous system tests suggest that application of the electric field does not interfere with cardiac or nervous system function.

Organ tissue tests suggest that healthy porcine and rabbit organ tissue is not damaged by application of the electric field at or approaching therapeutic levels.

Histological examination of healthy canine prostate tissue exposed to appropriate treatment levels indicates no noticeable damage to the healthy tissue as a result of treatment. Post-treatment health exams on this canine population showed no adverse effect on urinary, bowel or sexual function.

The above-described observations suggest that LDAC holds considerable promise in clinical use for the preferential treatment of a number solid cancer tumor types. The results of these studies strongly suggest that when treatment conditions are optimized, LDAC effectively destroys malignant tissue, leaving most healthy tissue intact. Lazure has elected to pursue the treatment of localized prostate cancer as its first approved indication for clinical use. However, preclinical results indicate that the technology may be effective in treating a number of solid tumor cancer types for which LaZure will seek regulatory approvals for in the future.

First-In-Man-Study

The Company has also completed development of an LDAC device which is appropriate for investigational use in human clinical studies for the treatment of early stage prostate cancer. To date 46 prostate cancer patients have been treated in two international trial locations.